1. Field of the Invention
The present invention relates to a hormonal contraceptive consisting of 21 to 25 hormone-containing daily units containing a combination of ethinyloestradiol in amount less than or equal to 25 μg and chlormadinone acetate in amounts of less than or equal to 5 mg, and optionally 7 to 3 daily units for oral administration to women.
In contraceptives, a combination of an oestrogen and a gestagen is conventionally administered per daily unit, wherein the amount of oestrogen should be kept as low as possible.
For all women, but in particular for women over 35 and in particular for women in the pre- and perimenopause, a hormonal contraceptive with the lowest possible amount of oestrogen is desirable, since from the age of 35 women have a greater risk of suffering complications caused by oestrogen-containing contraceptives, such as heart attack, stroke and lower limb thrombosis, followed by pulmonary embolisms.
2. Brief Description of Related Developments
It is already known from the prior art to use a combination of 30 μg of ethinyloestradiol and 2 mg of chlormadinone acetate for contraception and optionally for simultaneous treatment of acne. There is additionally a need to reduce still further the amount of ethinyloestradiol, which is combined with chlormadinone acetate, provided that reliable contraceptive action is nevertheless still guaranteed.
Furthermore, the contraceptive action of combined preparations of 15 μg of ethinyloestradiol and 60 μg of gestodene, which are administered for 24 days per cycle, is already known (Sullivan et al, Fertility and Sterility 72 (1999) 115-120; Gestodene Study Group 322, The European Journal of Contraception and Reproductive Health Care 4 (Suppl. 2) (1999) 9-15). However, gestodene does not ensure the advantageous properties of chlormadinone acetate.
Further combined preparations for hormonal contraception and for simultaneous treatment of complaints in the pre- and perimenopause are known from EP 0 398 460 and EP 0 253 607; these do not contain any chlormadinone acetate as the gestagen, however.